INSTRUCTIONS FOR USE
WEGO PGA (POLYGLYCOLIC ACID) STERILE SYNTHETIC ABSORBABLE SURGICAL
SUTURES
DESCRIPTION
WEGO SYNTHETIC ABSORBABLE SUTURES PGA (Polyglycolic Acid) are synthetic, absorbable
sterile surgical sutures composed of a Polyglycolic Acid (PGA).
The WEGO PGA sutures are coated with polycaprolactone and calcium stearate, which have been
found to be inert, non antigenic and non pyrogenic. PGA sutures are undyed and dyed in violet with
D&C violet #2.
WEGO SYNTHETIC ABSORBABLE SUTURES PGA (Polyglycolic Acid) are available in a range of
gauge sizes and lengths, attached to stainless steel needles of varying types and sizes.
WEGO SYNTHETIC ABSORBABLE SUTURES PGA (Polyglycolic Acid) comply with the
requirements of the European Pharmacopoeia for Sterile Synthetic Absorbable Braided Sutures and
the United States Pharmacopoeia monograph for synthetic absorbable surgical sutures.
INDICATIONS
The Synthetic Absorbable Surgical Sutures with Needle are intended for use in general soft tissue
approximation and/or ligation, including use in ophthalmic surgery, peripheral nerve anastomosis
and microsurgery for vessels less than 2mm diameter. The safety and effectiveness of WEGO
SYNTHETIC ABSORBABLE SUTURES PGA (Polyglycolic Acid) in cardiovascular tissue and
neurological tissue have not been established.
APPLICATION
Sutures should be selected and implanted depending on patient condition, surgical experience,
surgical technique and wound size.
PERFORMANCE
The Absorbable Suture with Needle elicits a minimal initial inflammatory reaction in tissues and
ingrowth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption
of the sutures occurs by means of hydrolysis, where the PGA polymer degrades to glycolic which
are subsequently absorbed and metabolized in the body.
Absorption begins as a loss tensile of strength followed by a loss of mass. The tensile strength
retains approximately 65% of the original value at 2 weeks post implantation. Absorption of WEGO
SYNTHETIC ABSORBABLE SUTURES PGA (Polyglycolic Acid) is essentially complete between
60 and 90 days.
CONTRAINDICATIONS
This suture, being absorbable should not be used where extended approximation of tissues under
stress is required.
This suture should not be used in patients with known sensitivities and allergies to its components.
WARNINGS / PRECAUTIONS / INTERACTIONS
Users should be familiar with surgical procedures and techniques involving absorbable sutures
before employing this suture for wound closure, as risk of wound dehiscence may vary with the site
of application and the suture material used. Surgeons should consider the in vivo performance
(described in PERFORMANCE section) when selecting a suture.
As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in
the urinary or biliary tracts, may result in calculus formation. As an absorbable suture it may act
transiently as a foreign body.
Acceptable surgical practice should be followed for the management of contaminated or infected
wounds.
As this is an absorbable suture material, the use of supplemental non-absorbable sutures should be
considered by the surgeon in the closure of the sites which may undergo expansion, stretching or
distension, or which may require additional support.
Skin sutures which must remain in place longer than 7 days may cause localized irritation and
should be snipped off or removed as indicated.
Under some circumstances, notably orthopaedic procedures, immobilisation of joints by external
support may be employed at the discretion of the surgeon.
Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as
suture extrusion and delayed absorption may occur. Subcuticular sutures should be places as
deeply as possible to minimize the erythema and induration normally associated with the absorption
process.
This suture may be inappropriate in elderly, malnourished or debilitated patients, or in patients
suffering from conditions which may delay wound healing.
When handling this or any other suture, care should be taken to avoid damage. Avoid crushing or
crimping damage due to the application of surgical instruments such as forceps or needle holders.
Care should be taken to avoid damage when handling surgical needles. Grasp the needle in an
area one-third (1/3) to one half (1/2) of the length of the needle from the swaged end to the needle
point. Grasping of the needle in the point area could impair the penetration performance and cause
fracture of the needle.
Grasping too close to the swaged end of the needle could cause bending or breakage of the needle.
Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.
Users should exercise caution when handing surgical needles to avoid inadvertent needle stick
injury. Discard used needles in “Sharps” container.
Adequate knot security requires the standard surgical technique of flat and square ties with
additional throws as indicated by surgical circumstances and the experience of the surgeon.
ADVERSE REACTIONS
Adverse reactions associated with the use of this device include transitory local irritation at the
wound site, transitory inflammatory foreign body response, erythema and induration during the
absorption process of subcuticular sutures. Like all foreign bodies this suture may exacerbate an
existing infection.
STERILITY
The Synthetic Absorbable Surgical Suture with Needle is sterilized by ethylene oxide gas. Do not
resterilize. Do not use if package is opened or damaged. Discard opened, unused sutures.
STORAGE
WEGO SYNTHETIC ABSORBABLE SUTURES PGA should be stored at a temperature below 25 ℃,
away from moisture and direct heat. Do not use after expiry date.
SYMBOLS USED ON LABELLING
Do not re-use
Batch code
Used by date
Date of manufacture
Manufacturer
Keep dry
Keep away from sunlight
Upper limit of temperature
Sterilized using ethylene oxide
Caution, consult accompanying document
Authorised representative in the European community